MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for AXOR II 1288 manufactured by Integrum Ab.
[118550680]
[(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[118550681]
Report from treating physician (b)(6) 2018: patient 1004 received a loaner axor ii failsafe device on (b)(6) 2018. She messaged matthew garibaldi on (b)(6) 2018 to state that "i had my leg come off a few hours ago... " i was leaning against the sink talking to my niece and my leg popped off".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011386779-2018-00009 |
| MDR Report Key | 7817909 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-26 |
| Date of Event | 2018-08-02 |
| Report Date | 2018-08-09 |
| Date Reported to Mfgr | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NIKLAS HOFVERBERG |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43137 |
| Manufacturer G1 | INTEGRUM AB |
| Manufacturer Street | KROKSLATTS FABRIKER 50 |
| Manufacturer City | MOLNDAL, VASTRA GOTALAND 43137 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXOR II |
| Generic Name | OPRA IMPLANT SYSTEM |
| Product Code | PJY |
| Date Received | 2018-08-27 |
| Model Number | 1288 |
| Catalog Number | 1288 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRUM AB |
| Manufacturer Address | KROKSLATTS FABRIKER 50 MOLNDAL, VASTRA GOTALAND 43137 SW 43137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-27 |